Advocacy News

On May 23, the Trump Administration released the President’s budget proposal for Fiscal Year (FY) 2018. The proposal calls for astonishingly deep cuts of $7.16 billion to the National Institutes of Health (NIH) and $1.2 billion to the Centers for Disease Control and Prevention (CDC). Because NIH funds most research projects over the course of multiple years, such a large funding drop could prevent the agency from awarding any new grants for deserving research projects in the coming fiscal year. In addition, the CDC’s highly successful Diabetes Prevention Program, which has been shown to reduce the risk of developing diabetes in adults over 60 years of age by 71 percent, would be severely curtailed. The Endocrine Society strongly opposes the budget proposal, given the potentially huge negative impacts on biomedical research and disease prevention.

Although the President’s Budget is principally a statement of administrative priorities and does not carry the force of law, the Endocrine Society is disappointed that the Administration seeks to reverse the substantial progress made in recent years to provide steady, sustainable increases to the NIH budget. Attention now turns to the Congress, where legislators will begin working on the appropriations bills to fund federal agencies through FY 2018. The Endocrine Society will continue to advocate for an NIH appropriation of at least $36.1 billion, representing a $2 billion increase over FY 2017. We argue that this is the minimum investment necessary to place NIH on a sustainable path forward and recover losses due to inflation over the past 15 years.

Society Signs Amicus Brief for G.G. v Gloucester

An amicus brief was submitted on behalf of 16 medical and mental health organizations, including the Endocrine Society, to the Fourth Circuit Court of Appeals in support of the plaintiff. G.G. v Gloucester County School Board was brought before the court by a transgender student in Gloucester County, VA because he was prohibited from using the bathroom at school that matched his gender identity. The brief informed the Court of the medical consensus regarding what it means to be transgender; the protocols for the treatment of gender dysphoria; and the predictable harms to the health and well-being of transgender adolescents when they are excluded from restrooms that match their gender identity.

The case was previously before the Supreme Court but was vacated and remanded to the Fourth Circuit Court following the Trump Administration's decision to withdraw previous federal guidance that said school divisions must allow transgender students to use the bathroom matching their gender identity.

Personal Care Products Safety Act Re-introduced

On Thursday, May 11, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) re-introduced the Personal Care Products Safety Act (PCPSA) in the 115th Congress. The PCPSA would, if passed, set a rigorous safety standard for personal care products and provide the public with more information about the chemicals in the products they are purchasing. Furthermore, the bill would allow the Food and Drug Administration (FDA) to collect information on the ingredients of personal care products (e.g. cosmetics, lotions, shampoos), and prohibit distribution of a product if an ingredient could cause serious adverse health consequences. It would also require the FDA to review the safety of at least five ingredients each year.

Several improvements to the bill were made prior to reintroduction. The bill now requires the FDA to explain decisions about ingredient safety in a consumer-friendly way. The FDA would also be permitted to review a category, or class of chemicals for safety, as well as individual chemicals. The bill also provides additional flexibility in registration for companies generating less than $2 million in revenue.

The Endocrine Society continues to support the PCPSA and we are encouraged by the improvements to the bill. On May 25, the Endocrine Society met with members of the Senate Health, Education, Labor, and Pensions (HELP) committee to gather additional cosponsors for the bill and raise its priority in the Congress. The Endocrine Society will continue to monitor the bill and keep members informed of progress and opportunities to support.

Clinical News

QPP Technical Assistance Resource Guide Now Available

The Centers for Medicare and Medicaid Services (CMS) has published the Technical Assistance Resource Guide to highlight the opportunities for support for clinicians participating in the Quality Payment Program (QPP). It contains brief summaries on each branch of technical assistance, contact information, and maps to illustrate coverage areas. The tool can be accessed on the Education and Tools section of the CMS QPP website.

2017 is the transition year for the QPP, the new Medicare payment system that pays based on the value rather than the volume of services. Additional information on the program can be found on the Society’s QPP webpage.

Research News

NIH Proposes to Limit Total Grant Support to Individual Investigators

This month, the National Institutes of Health (NIH) proposed a new policy to place a cap on total research support that may be received by an individual investigator from the NIH based on a new index called the Grant Support Index (GSI). The policy is aimed at addressing the hyper-competitive atmosphere in biomedical research and supporting a more stable research workforce. Although many details about the GSI calculation have yet to be finalized, the NIH has stated that the GSI cap for researchers will be 21, equivalent to 3 R01 grants.

Our understanding is that the GSI will be similar in principle to the Research Commitment Index. Using this index, large grants (e.g., P50, U54) will have a score of 11, R01s and similar grants have a score of 7, and grants requiring less substantial commitments (e.g., R21, R03) have comparatively lower scores. Grants with multiple Principal Investigators (PIs) will have slightly decreased point assignments for each investigator. The NIH will calculate GSI for all applicants, and applicants would be required to submit a plan to reduce their GSI to remain within the cap, should a new grant award cause their GSI to extend above the cap. The NIH will not cancel any existing grants under the new policy; enforcement of the cap only applies to new applications. The NIH estimates that roughly 6% of supported investigators will be affected by the new cap, while around 1,600 new awards would become available in the ensuing years to broaden the pool of NIH-funded researchers.

The NIH has proposed an aggressive schedule for implementing the new policy with grant applications starting in September. An analogous policy may also be implemented for the intramural campus. Over the summer, the NIH will collect feedback from Advisory Councils and other stakeholders. A website will also be developed to solicit public comments. For more information, members can examine the Open Mike blog, or announcements from the NIH Director’s page. The Endocrine Society will closely monitor this rapidly evolving policy and we encourage members to contact the Government and Public Affairs team at jlaakso@endocrine.org with your thoughts or questions on the policy and how it might affect you.

Congress Holds Hearings on NIH Oversight, Indirect Costs

NIH Oversight Hearing

On Wednesday, May 17, the House Appropriations Subcommittee on Labor, Health and Human Services (LHHS) held a hearing focused on the NIH and advances in biomedical research. Witnesses for the hearing included NIH Director Francis Collins, MD, PhD and the Directors of several individual NIH Institutes.

During his opening remarks Subcommittee Chairman Tom Cole (R-OK) spoke against cutting the NIH budget and recognized that biomedical research supported by NIH is necessary to rein in the growth in healthcare costs in the United States. Statements by several other subcommittee members, including Ranking Member Rosa DeLauro (D-CT) emphasized the need to support increased funding for NIH to accelerate lifesaving biomedical research and recruit and retain young researchers in the pipeline.

Endocrine research priorities also came up in the course of the hearing. In response to questions from subcommittee members, Dr. Collins noted that the artificial pancreas holds great promise for mitigating costs associated with care for patients with diabetes; he also discussed progress and developments on the Environmental Influences on Child Health Outcomes (ECHO) cohort program. Representative Nita Lowey (D-NY) urged NIH to make progress in kidney and pancreatic cancer, and Representative DeLauro expressed interest in progress made by NIH to balance the study of sex and gender in biomedical research.

Subcommittee members also expressed concern about ongoing budgetary battles and their effects on the NIH. In particular, the effects of hiring freezes, budget shutdowns, and continuing resolutions. To see a recording of the entire hearing, please see the Subcommittee website.

Hearing on Indirect Costs

On Wednesday, May 24, the House Committee on Science, Space, and Technology held a joint Research and Technology Subcommittee and Oversight Subcommittee hearing on examining the overhead costs of research. Witnesses at the hearing included Mr. Dale Bell, Division Director, Institution and Award Support, National Science Foundation (NSF); Mr. John Neumann, Director, Natural Resources and Environment, U.S. Government Accountability Office (GAO); Mr. James Luther, Associate Vice President of Finance & Compliance Officer, Duke University; and Dr. Richard Vedder, Distinguished Professor of Economics Emeritus, Ohio University.

During the hearing, participants discussed factors and considerations that reflect the diverse indirect cost rates negotiated between institutions and the federal government related to research supported by agencies including the NIH and National Science Foundation (NSF). Witnesses noted that indirect rates support expensive laboratory infrastructure, such as animal facilities and high-efficiency particulate air filters, in addition to general facilities and administrative (F&A) costs. In response to questions, witnesses discussed how different research programs may incur different F&A costs, including regulatory and compliance activities, and that some of these costs may be quite high for biomedical research, relative to other research projects. Mr. Luther noted that the negotiated rates do not allow some institutions to cover all of the costs to support cutting-edge research programs.

Dr. Vedder suggested that a flat indirect cost rate applied to all institutions might be more efficient, and reduce administrative expenses associated with negotiation and reporting. Other witnesses suggested that administrative burdens and associated costs could be more efficiently reduced by implementing recommendations issued by a recent report from the National Academies of Sciences, Engineering, and Medicine.

The Endocrine Society will continue to monitor congressional interest in indirect costs; to see an online recording of the hearing, please see the full committee website.

NIDDK Advisory Council Discusses Precision Medicine, New NIH Policy

On May 10, the Endocrine Society participated in a meeting of the National Diabetes and Digestive and Kidney Diseases (NIDDK) Advisory Council. Society members Lee Kaplan, MD, PhD; Alan Saltiel, PhD; Jeffrey Pessin, PhD; and Joel Elmquist, PhD, DVM, are members of the Council, which advises the Director of the NIDDK on research, support activities, and functions of the Institute.
During the meeting, Eric Dishman, Director of the Precision Medicine Initiative (PMI) Cohort Program joined the Council to discuss the “All of Us” research program. Mr. Dishman described the goals of the All of Us program, to deliver a large, rich dataset that researchers and funders can use that is easy to access and safe for research participants. The program hopes to catalyze an ecosystem of researchers and funders to address a broad spectrum of diseases and accelerate patient participation and discoveries. Mr. Dishman also discussed the anticipated challenges of building relationships with over 1 million research participants from all walks of life and include them as partners in the project. However, with new engagement methodologies, he hopes to build a cohort that covers a broad cross section of Americans from all walks of life, and reflect the inclusion of demographic subgroups that are typically underrepresented in biomedical research.

Council members were curious about how the All of Us program would result in new interventions and changes in clinical practice. In response to questions, Mr. Dishman also explained the curation and quality control processes for the dataset and how they are approaching the creation of synergies with other cohort studies such as the Environmental Impacts on Child Health Outcomes (ECHO) program. Council encouraged Mr. Dishman to think about how the All of Us program could be used to accelerate the process around preventing disease.

Dr. Larry Tabak, DDS, PhD, Principal Deputy Director at NIH, then joined the Council to discuss the new NIH policy to limit grant support by an individual investigator (see Endocrine Insider article above for more information on the GSI policy). Council members acknowledged that some sort of policy to support investigators across career stages was needed, but cautioned that this could be a challenging issue for many senior scientists. Council strongly encouraged Dr. Tabak to share the data sets, methodology, and analysis that NIH used to develop the new policy. They also shared concerns that the new policy would disadvantage those investigators who submit applications for resource development, such as center grants, or training grants, as these activities can be considered a service to the university and generally do not contribute to the operation of the principal investigator’s lab or their salary. Dr. Tabak acknowledged that the new policy would need to more thoughtfully address such grants.

During a follow-up discussion on the GSI policy at the Diabetes, Endocrinology and Metabolism Subcommittee, subcommittee members cautioned that NIH would need to establish clear guidelines for investigators who want to hand off their grant to another investigator. They also thought that the new policy might incentivize researchers to apply for larger grants with more direct costs, instead of multiple R01s. Institutes would also need to consider how the policy might impact their use of P-series program project grants.